Bipolar DisorderEMITTER3PSYNCT01804257
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study
A study testing Digital Health Feedback System in people with Bipolar Disorder and Schizophrenia, run by Proteus Digital Health, Inc. at 2 sites in United States.
Trial summary
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- What is being tested?
- Digital Health Feedback System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 and ≤ 65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:
- Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder
- Clinical global impression scale-severity (CGI-S) of 3 or below
- Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
- No anticipation to change or titrate the regimen in the next 28 days
- Willingness to adhere to study procedures
- Capacity to provide informed consent
Who cannot join
- Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
- Serious suicide or homicide risk, as assessed by evaluating clinician
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
- A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
- Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia
Show all 12Show fewer
- History of significant gastrointestinal disease or major gastrointestinal surgery
- Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study
- Known allergies that could preclude safe participation in the study
- Current presence of an electronically active implanted medical device
- Participation in another medical device study, or on any investigational drug or device within the last 30 days
- Inability to obtain consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02116
Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Official title: Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.
Read the detailed description
In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication.
The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- Digital Health Feedback System
- Keywords
- Adherence, Bipolar disorder, Cellular phone, Cloud computing, Computers, Computers, handheld, Digital health, Digital health feedback system, Ingestion Sensor, Medication adherence, Medication non-adherence, Medication nonadherence, Mobile phone, Mobile health, Patient adherence, Patient non-adherence, Patient nonadherence, Schizophrenia, Telehealth, Telemedicine
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Feedback SystemOther
Also called Ingestible sensor, Wearable sensor
The digital health offering passively collects and records medication-taking behavior and other habits of daily living
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Feedback System (DHFS) | Experimental | Ingestion Sensor, Wearable Sensor Receives: Other: Digital Health Feedback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Detection Accuracy
Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.
Measured: 4 weeks
Secondary outcomes (1)
System Safety
Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteus Digital Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, The Zucker Hillside Hospital
- Responsible party
- Sponsor
- Investigators
- John M Kane, MD, Principal investigator, The Zucker Hillside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804257
- Sponsor's protocol ID
- EMITTER 3.0 PSY
- Acronym
- EMITTER3PSY
- Status last verified
- Mar 2013
- First submitted
- 27 Feb 2013
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013 Jun;74(6):e533-40. doi: 10.4088/JCP.12m08222.
PubMed 23842023
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study (EMITTER 3.0 PSY)
- ClinicalTrials.gov ID
- NCT01804257
- Acronym / sponsor ID
- EMITTER3PSY / EMITTER 3.0 PSY
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- Adherence, Bipolar disorder, Cellular phone, Cloud computing, Computers, Computers, handheld, Digital health, Digital health feedback system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Proteus Digital Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, The Zucker Hillside Hospital
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.
Detailed description
In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication.
The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Health Feedback System (DHFS) | Experimental | Other: Digital Health Feedback SystemIngestion Sensor, Wearable Sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥ 18 and ≤ 65 years of age
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:
- Clinical global impression scale-severity (CGI-S) of 3 or below
- Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
- No anticipation to change or titrate the regimen in the next 28 days
Key exclusion criteria (12 listed)
- Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
- Serious suicide or homicide risk, as assessed by evaluating clinician
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
- A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Feedback SystemAlso: Ingestible sensor, Wearable sensorThe digital health offering passively collects and records medication-taking behavior and other habits of daily living | Other | Digital Health Feedback System (DHFS) |
Primary outcome
Positive Detection Accuracy
Time frame: 4 weeks
Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.
1 secondary outcome
System Safety
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23842023Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013 Jun;74(6):e533-40. doi: 10.4088/JCP.12m08222.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Kane, MD principal investigator
The Zucker Hillside Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Feedback System in people with Bipolar Disorder and Schizophrenia, run by Proteus Digital Health, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Detection Accuracy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.